Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Cstone, Everest, Ligand, Oncolys, Oncopeptides, Roche, Satsuma.
While privately held Levo Therapeutics Inc.’s phase III study of LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome (PWS) failed to meet its primary outcome measurements, the company’s CEO told Bioworld the first secondary endpoint showed a statistical significance that raised her hopes the FDA might approve the selective oxytocin-receptor agonist for the indication.
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest.
HONG KONG – Incheon, South Korea-based Celltrion Inc. is rapidly advancing CT-P59, its antiviral antibody treatment for the COVID-19 virus, after receiving its second green light to begin phase I trials.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angion, Arch, Avelas, Cellectar, Clene, Karuna, Keros, GT, Novartis, Oncopeptides, Regenxbio.
Since more than 40% of U.S. coronavirus deaths have links to U.S. long-term care facilities, Eli Lilly and Co. is getting on the road with a clinical trial design that takes researchers directly to outbreaks.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
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